Adult Acute Lymphocytic LeukemiaPhase 4NCT00199095
Treatment of Elderly Patients (>65 Years) With Acute Lymphoblastic Leukemia
A Phase 4 study testing Adriamycin, Cyclophosphamide and Cytarabine in people with Adult Acute Lymphocytic Leukemia, run by Goethe University at 1 site in Germany.
Trial summary
The aim of this study is to test feasibility and efficacy of a dose reduced chemotherapy in elderly patients with newly diagnosed acute lymphoblastic leukemia. The regimen consists of induction phase I and II followed by cyclic consolidation cycles, reinduction and maintenance therapy Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Adult Acute Lymphocytic Leukemia
- What is being tested?
- Adriamycin, Cyclophosphamide and Cytarabine
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- Feb 1997to Jun 2003
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- diagnosis of acute lymphoblastic leukemia (pro-B,common,pre-B,pre-T,Thy-,mature T, B-ALL)
- age > 65 years
- written informed consent
- Karnofsky > 50% (if not mainly caused by leukemia)
- laboratory at diagnosis or after supportive pre-treatment Creatinine < 2 mg/dl Uric Acid < 8 mg/dl Bilirubin < 1.5 mg/dl ALA, ASA,AP < 2.5 x ULN
Who cannot join
- severe second diseases (e.g. renal failure, cardiomyopathy etc., not caused by leukemia) that exclude treatment according to the protocol
- severe psychiatric illness or other circumstances which may compromise cooperation
- active second neoplasia
- clinical signs of life threatening infections or bleeding, uncontrollable prior to chemotherapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study for Treatment of Elderly Patients (>65 Years) With Acute Lymphoblastic Leukemia
The aim of this study is to test feasibility and efficacy of a dose reduced chemotherapy in elderly patients with newly diagnosed acute lymphoblastic leukemia. The regimen consists of induction phase I and II followed by cyclic consolidation cycles, reinduction and maintenance therapy
- Conditions
- Adult Acute Lymphocytic Leukemia
- Being tested
- Adriamycin, Cyclophosphamide, Cytarabine, Dexamethasone, Idarubicin
- Keywords
- ALL, Elderly, Chemotherapy
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdriamycinDrug
CyclophosphamideDrug
CytarabineDrug
DexamethasoneDrug
IdarubicinDrug
IfosfamideDrug
MethotrexateDrug
MercaptopurineDrug
VM26Drug
VincristineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Results of induction therapy,Distribution of entry criteria,Treatment feasibility,Relapse rate and localisation,Death in CR,Remission duration, survival and leukemia free survival,Prognostic factors,Quality of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startFeb 1997
- Primary completionJun 2003
- Study completionJun 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adult Acute Lymphocytic LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- Goethe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicola Goekbuget, Goethe University
- Investigators
- Dieter Hoelzer, MD, Study chair, University Hospital Frankfurt, Medical Dept. II
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00199095
- Sponsor's protocol ID
- GMALL11
- Status last verified
- Mar 2023
- First submitted
- 12 Sep 2005
- Last updated
- 20 Mar 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study for Treatment of Elderly Patients (>65 Years) With Acute Lymphoblastic Leukemia
- ClinicalTrials.gov ID
- NCT00199095
- Acronym / sponsor ID
- GMALL11
- Conditions
- Adult Acute Lymphocytic Leukemia
- Keywords
- ALL, Elderly, Chemotherapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants
- Lead sponsor
- Goethe UniversityUniversity, hospital or other
- Study start
- Feb 1997 (actual)
- Primary completion
- Jun 2003 (actual)
- Study completion
- Jun 2003 (actual)
- First posted
- 20 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to test feasibility and efficacy of a dose reduced chemotherapy in elderly patients with newly diagnosed acute lymphoblastic leukemia. The regimen consists of induction phase I and II followed by cyclic consolidation cycles, reinduction and maintenance therapy
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- diagnosis of acute lymphoblastic leukemia (pro-B,common,pre-B,pre-T,Thy-,mature T, B-ALL)
- age > 65 years
- written informed consent
- Karnofsky > 50% (if not mainly caused by leukemia)
- laboratory at diagnosis or after supportive pre-treatment Creatinine < 2 mg/dl Uric Acid < 8 mg/dl Bilirubin < 1.5 mg/dl ALA, ASA,AP < 2.5 x ULN
Key exclusion criteria (4 listed)
- severe second diseases (e.g. renal failure, cardiomyopathy etc., not caused by leukemia) that exclude treatment according to the protocol
- severe psychiatric illness or other circumstances which may compromise cooperation
- active second neoplasia
- clinical signs of life threatening infections or bleeding, uncontrollable prior to chemotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adriamycin | Drug | – |
| Cyclophosphamide | Drug | – |
| Cytarabine | Drug | – |
| Dexamethasone | Drug | – |
| Idarubicin | Drug | – |
| Ifosfamide | Drug | – |
| Methotrexate | Drug | – |
| Mercaptopurine | Drug | – |
| VM26 | Drug | – |
| Vincristine | Drug | – |
Primary outcome
Results of induction therapy,Distribution of entry criteria,Treatment feasibility,Relapse rate and localisation,Death in CR,Remission duration, survival and leukemia free survival,Prognostic factors,Quality of life
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dieter Hoelzer, MD study chair
University Hospital Frankfurt, Medical Dept. II
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Adriamycin, Cyclophosphamide and Cytarabine in people with Adult Acute Lymphocytic Leukemia, run by Goethe University at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Results of induction therapy,Distribution of entry criteria,Treatment feasibility,Relapse rate and localisation,Death in CR,Remission duration, survival and leukemia free survival,Prognostic factors,Quality of life. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2023.